UnknownPhase 2

Efficacy and Safety of CsA+AVA in the Treatment of NSAA in the Elderly

China30 participantsStarted 2023-08-17

Plain-language summary

For elderly patients who cannot tolerate anti-thymocyte globulin (ATG) treatment, the addition of avatrombopag (AVA), which has a slight adverse reaction, can theoretically improve the hematological response rate in elderly patients with non-severe aplastic anemia (NSAA) without significantly increasing adverse reactions. Based on this, this study treated NSAA patients older than 60 with AVA combined with CsA to evaluate the hematological response rate and safety of AVA in the elderly who could not tolerate ATG therapy.

Who can participate

Age range60 Years – 90 Years

SexALL

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Inclusion criteria

✓. Elderly patients with well-defined NSAA anemia who meet the diagnostic criteria for aplastic anemia (AA) but do not meet the diagnostic criteria for severe aplastic anemia (SAA).
✓. Age 60 years or older, male or female.
✓. Able to swallow or administer orally.
✓. Intolerant or refused anti-thymocyte globulin treatment

Exclusion criteria

✕. Known congenital AA (such as Fanconi anemia) and other causes of pancytopenia and hematological bone marrow disorders;
✕. With paroxysmal nocturnal hemoglobinuria (PNH) clone ≥ 50%
✕. With a history of hematopoietic stem cell transplantation.
✕. History of thrombosis
✕. Patients with underlying cancer who also have malignant tumors or are receiving immunosuppressive therapy.
✕. Baseline creatine levels greater than twice of the upper limit of normal (ULN) and/or alanine aminotransferase (ALT) greater than 2.5 times of the ULN;
✕. Serious heart, liver and kidney disease.
✕. With uncontrolled bleeding and/or infection after standard treatment.

What they're measuring

ORR at 6 Months

Timeframe: 6 months

Trial details

NCT IDNCT06004752

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08

Contact for this trial

Bing Han

+861069151235 hanbing_li@sina.com

View on ClinicalTrials.gov More Aplastic Anemia trials